The Scleroderma Patient-Centered Intervention Network Self-Management Program: Protocol for a Randomized Feasibility...

Area of Science:

• Rheumatology
• Digital Health
• Health Services Research

Background:

• Systemic sclerosis (SSc) significantly impacts daily living and well-being.
• Current SSc treatment focuses on symptom management and improving quality of life.
• Web-based self-management programs show promise for enhancing self-efficacy in chronic diseases.

Purpose of the Study:

• To assess the feasibility of a full-scale randomized controlled trial (RCT) for the SPIN-SELF program.
• To evaluate implementation processes, resources, scientific aspects, and participant engagement.
• To guide necessary adjustments before a large-scale RCT.

Main Methods:

• A feasibility trial using the SPIN Cohort and a cohort multiple RCT design.
• 40 SSc participants with low self-efficacy randomized (3:2) to SPIN-SELF or usual care for 3 months.
• Feasibility outcomes included trial processes, resources, scientific validity, and user acceptability.

Main Results:

• Participant enrollment completed between July 5-27, 2019.
• Data collection concluded by November 25, 2019.
• Data analysis is ongoing; results anticipated in 2020.

Conclusions:

• The SPIN-SELF program may enhance self-management self-efficacy and HRQoL in SSc patients.
• The feasibility trial ensures robust and acceptable trial methodology.
• Findings will inform adjustments for a future full-scale RCT.